MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During procedure while using laparoscopic clip applier el5ml, md states that the clip applier was "misfiring".Second clip applier was opened and md reported second clip applier was doing the same thing.A third clip applier was opened and md reported it was working properly.Fda safety report id# (b)(4).

• Brand Name: ETHICON
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 8931194
• MDR Text Key: 155668863
• Report Number: MW5089304
• Device Sequence Number: 0
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR